Lifestyle Intervention: Pilot Study for people with schizophrenia treated with either clozapine or another antipsychotic medication

Category Primary study
Registry of TrialsANZCTR
Year 2019
INTERVENTION: A lifestyle intervention including a combination of low grade physical activity and targeted dietary modification would be supported and monitored by the research team together with clients’ Mental Health case manager, clozapine coordinators, consumer volunteers, and/or their NDIS or Community managed organisation support worker. The lifestyle intervention will run for three months. Dietary component The dietary intervention will consist of an individualised dietary assessment using online the Australian Eating Survey (AES) which identifies key areas that require change. Intake from each of the food groups is subsequently used to calculate an individual's macronutrient and micronutrient intake. At the end of the dietary assessment participants will be provided with feedback which will be delivered face to face by a dietician with three goals: a) reducing sweetened drinks, b) reduction in discretionary foods and snacks c) increase core food intake. These factors have been shown to be prevalent issues in this population group and will lead to a reduction in total energy intake. Those in the control group will only be provided with this feedback and no other lifestyle intervention. They will continue to be case managed by the mental health service and receive ongoing psychiatric treatment for schizophrenia. Those in the intervention group will receive the three individual sessions delivered face to face by either dietician or clinical psychologist, at baseline, 2 months and 3 months which come from Food Fix programs. The dietician has over 10 of experience in delivering dietary interventions as well as having experience in delivering the Food Fix Program. The clinical psychologist has over 10 years of experience in providing clinical and lifestyle interventions to people with mental health problems The dietary sessions consist of: Session 1 consists of provision of feedback from the online survey and development of die CONDITION: Diet and Nutrition ‐ Obesity Mental Health ‐ Schizophrenia Schizophrenia;Overweight/obesity; ; Schizophrenia ; Overweight/obesity PRIMARY OUTCOME: Metabolic,risk factors measured by blood test (liver function, urea electrolytes and creatinine, a fasting lipid profile test , fasting blood glucose test ). This is a composite primary outcome[Baseline and 3 months] Cardiovascular risk measure by blood test (The troponin test)[Baseline and 3 months] Quality of life measured by self report Quality of life and General Health measure (AQol‐8D)[Baseline and 3 months ] SECONDARY OUTCOME: Overweight/obesity measured by BMI. BMI will be measured by collecting the weight and height of the participants. The weight will be meausred using a digital scale and the height will be measured using stadiometer. [Baseline and 3 months] INCLUSION CRITERIA: • Age ‐18‐65 years • Taking clozapine for at least 18 weeks and are in maintenance phase or • have been taking another antipsychotic medication for at least 6 months • Are overweight or obese – BMI greater than 25 • Have access to transport – either by having their own car, or living in the area and near a bus stop, or have an NDIS support worker who can bring them
Epistemonikos ID: 7a2878cd185f936658c43957d7a2e3baefbb843b
First added on: Aug 24, 2024